MAKO Surgical Settles in Lawsuit Involving Allegedly Botched MAKOplasty Surgery
On May 4th we published a note about Dr. John Velyvis’s termination by Adventist Health California Medical Group (CMG). Dr. Velyvis formerly practiced at St. Helena’s Coon Joint Replacement Institute with Dr. Thomas Coon and Dr. Adam Freedhand. CMG Adventist Health California Medical Group, Inc., Adventist Health, St. Helena Hospital, and Adventist Health Physician’s Network are related entities.
According to court documents (Velyvis v Adventist Health – Tentative Ruling) CMG terminated Dr. Velyvis at least in part for allegedly not performing surgeries with an appropriate standard of care. Dr. Velyvis was notified that he was being terminated on November 16, 2011 with an effective date of December 31, 2012 (later changed to January 31, 2012). Dr. Velyvis hired a law firm on November 22, 2011 to pursue a claim for wrongful termination and a lawsuit was filed on January 31st (Napa County Superior Court Case No. 26-58148, Dr. John H. Velyvis v. Adventist Health California Medical Group, Inc.). In that lawsuit, Velyvis applied for a preliminary injunction to force reinstatement pending resolution of the case. A tentative ruling came on March 2, 2012, when the court denied Velyvis’s request for injunctive relief. The tentative ruling said:
“… a balancing of the potential interim harms does not weigh strongly in plaintiff’s favor. If defendant’s contention that plaintiff was not performing surgeries with an appropriate standard of care proves correct, there would be a potentially significant interim harm involved if the court required his reinstatement to his surgical position pending a final determination in that regard can be made. Under these circumstances, the court exercises its discretion to deny the requested preliminary injunctive relief.
John Velyvis Enters Into Confidential Settlement Agreement with Adventist
On March 6, 2012, John Velyvis entered into a confidential settlement agreement with Adventist Health California Medical Group, Inc., Adventist Health, St. Helena Hospital, and Adventist Health Physician’s Network. In approving the settlement agreement in the lawsuit, which was reached in the midst of another proceeding, counsel for the Adventist defendants advised the court-appointed trustee “that it was an important deal point of the settlement to keep its terms, and the exhibits to the settlement agreement and mutual release confidential because they might “impact issues wholly unrelated to the concerns of this bankruptcy estate”. What those issues are is unclear.
Allegations Against MAKO Surgical – Negligence, Failure to Recall, Failure to Warn, Fraud – Concealment
On February 10, 2011, MAKO was named as one of multiple defendants in a lawsuit that involved an allegedly botched MAKOplasty surgery performed on November 9, 2009 by John Velyvis while he was at Eisenhower Medical Center (Superior Court of California, County of San Francisco Case Number: CGC-11-508163 subsequently transferred to Superior Court of California County of Riverside) – see Footnote 1.
As to MAKO, the causes of action in the malpractice and product defect suit were Strict Liability – Manufacturing Defect, Strict Liability – Failure to Warn, Negligence – Design, Manufacture and Sale, Negligence – Failure to Recall/Retrofit, Negligence – Failure to Warn, Fraud – Intentional Misrepresentation, and Fraud – Concealment.
On February 8, 2012, MAKO filed an application with the court to approve a settlement agreement prior to the malpractice case going to trial. The order approving the settlement was filed on March 19, 2012. Listed below are the complaint, MAKO Surgical’s application for a settlement agreement with the patient alleging he/she was injured during a MAKOplasty procedure and the court’s order on the agreement.
MAKOplasty Lawsuit Documents – Complaint, Settlement Agreement, Order on Settlement
- MAKOplasty Lawsuit – MAKO Surgical – Amended Complaint
- Second Amended Complaint
- MAKO Surgical – Application for Settlement Agreement
- Order Approving Settlement Agreement
MAKOplasty Adverse Event Filed with FDA Two Years Later – By the Allegedly Injured Patient, Not MAKO Surgical
The MAKOplasty patient’s adverse event described in the lawsuit is now in FDA’s MAUDE adverse event database. However, the event was not reported by MAKO – it was reported by the patient on October 17, 2011, four weeks prior to the day that Dr. Velyvis was notified by St. Helena that he was being terminated and two years after MAKO was notified of the event. Based on the allegations in the lawsuit (see selected portions below) one could reasonably conclude that MAKO failed to disclose an adverse event that was the very subject of a lawsuit in which it was a named defendant. Among other things, the lawsuit alleges that:
- MAKO was notified in writing 4 times of the event (“Even though Plaintiff notified MAKO in no less than 4 written communication (sic), MAKO represented to Plaintiff that it was unaware of any problems with Plaintiff’s November 2009 MAKOplasty”)
- The patient discussed “data issues and flaws” with James Palmer, MAKO’s Director of Quality, as well as discussing many other issues relating to this technology, investment in this product by EMC (Eisenhower Medical Center), DOC (Desert Orthopedic), the Doctors, and others all of whom Plaintiff alleges to have unconscionable financial interests at stake.”
Although the data issues and flaws that the plaintiff allegedly discussed with MAKO Surgical’s regulatory or quality assurance groups are unknown, readers may also be interested in an adverse event report related to a robotic arm malfunction that we discussed in another article.
Why Was MAKO Surgical Sued?
Selected Plaintiff Allegations against MAKO Surgical Include (emphasis added):
- After Plaintiff’s MAKOplasty, and after suffering from this procedure, Plaintiff finally discussed the patient data issues and flaws with James Palmer, MAKO’s Director of Quality, as well as discussing many other issues relating to this technology, investment in this product by EMC (Eisenhower Medical Center), DOC (Desert Orthopedic), the Doctors, and others all of whom Plaintiff alleges to have unconscionable financial interests at stake.
- Plaintiff also alleges that MAKO continues to fail to report accurately patient problems with the MAKOplasty procedure and that nothing about Plaintiff’s experience has been included in [MAKO Surgical's] public disclosures notwithstanding Plaintiff’s express disclosures to MAKO.
- Plaintiff [MAKOplasty patient] reported problems almost immediately to his home physical therapist including loud “catching” noises and severe pain in his right knee – much more pain than before the [MAKOplasty procedure]. Plaintiff was told that physical therapy would correct these problems and to continue to engage in physical therapy.
- Even though Plaintiff notified [MAKO Surgical] in no less than 4 written communication (sic), MAKO represented to Plaintiff that it was unaware of any problems with Plaintiff’s November 2009 [MAKOplasty procedure].
- This fact of course speaks volumes to the lack of empirical integrity of [MAKOplasty patient experiences] and data as reported in the various “white papers” published by MAKO.
- At or around the time Plaintiff complained to DOC, [Eisenhower Medical] and the Doctors, Dr. Velyvis was terminated from DOC. Plaintiff believes that the competence and skill of Dr. Velyvis was a material factor in the reason he left DOC and EMC.
Why Did MAKO Surgical File 120 MAKOplasty Adverse Events Late?
MAKO Surgical’s SEC Disclosures Regarding its “Retrospective Review” of MAKOplasty Product Complaints Ring Hollow: On May 7th MAKO Surgical filed its 10-Q for the quarter ended March 31, 2012. In the 10-Q MAKO disclosed that it had met with the FDA on the same day we published our note (May 4th) about Velyvis’s termination.
The 10-Q does not disclose whether the meeting between MAKO Surgical and the FDA took place at the behest of the FDA or was voluntary – MAKO merely states that it met with the FDA and during the meeting it solicited FDA’s advice on the “reasonableness” of (1) MAKO Surgical’s “enhanced MDR reporting systems” and (2) the results of an internally conducted retrospective review of MAKOplasty product complaints received by MAKO Surgical between 2010 and the present. The retrospective review of MAKOplasty complaints “preliminarily” identified 105 reportable MAKOplasty adverse events that MAKO had failed to report to the FDA. In addition, after discussing its enhanced MDR reporting system with the FDA an additional 15 reportable MAKOplasty adverse events were identified. As a result, MAKO submitted 120 MDR filings on May 7, 2012.
MAKO also states in its 10-Q that “In 2012, as part of our ongoing internal quality management initiatives and systems enhancements” it undertook a retrospective review of all MAKOplasty product complaints to determine if “we may have inadvertently failed to file certain Medical Device Reporting (“MDR”) reports with the U.S. Food and Drug Administration (the “FDA”) during the period 2010 to present.”
In other words, even though MAKO Surgical was involved in a product liability lawsuit involving an allegedly botched MAKOplasty procedure that was commenced on February 10, 2011 that explicitly alleged that MAKO Surgical had and continued to fail to “accurately [report] patient problems with the MAKOplasty procedure and that nothing about Plaintiff’s experience has been included in MAKO’s public disclosures”, MAKO passed off the retrospective review as a mere act of corporate integrity; specifically, MAKO Surgical claimed that the review was conducted because the company takes “matters relating to regulatory compliance very seriously”. Indeed, MAKO takes regulatory compliance so seriously that it wanted to make sure that it had not “inadvertently failed to file certain Medical Device Reporting (“MDR”) reports with the U.S. Food and Drug Administration”, including an MAKOplasty adverse event that was the subject of a MAKOplasty lawsuit in which MAKO Surgical was a named defendant and for which it settled for an undisclosed sum of money.
Another Malpractice Suit Involving MAKOplasty Procedure - Hachigian v. Paul K. Gilbert, M.D.
According to a report in the Daily Journal, a medical malpractice suit involving a MAKOplasty procedure performed on July 27, 2009 was filed in Los Angeles Superior Central (Michael M. Hachigian v. Paul K. Gilbert, M.D./BC445673). Among the Plaintiff’s allegations were that he did not give his informed consent as Defendant did not disclose to him that Plaintiff would be Defendant’s first patient to undergo a partial knee replacement with the use of CT navigation and the Mako Robot. According to the Defendant, he “believed he told Plaintiff that Plaintiff would be Dr. Gilbert’s first private patient to undergo this procedure where Dr. Gilbert was assisted by the Mako Robot”.
At the start of trial, the Defendant offered $29,999 to settle the case. The Plaintiff claimed persistent disabling pain in the left knee requiring a total knee replacement and claimed that “Plaintiff’s active retirement quality of life (golf, tennis, swimming, walking) has been severely diminished.”
The malpractice case proceeded and ended with a verdict in favor of the defense. We’ve searched the FDA’s MAUDE adverse event database and there does not appear to be any entry related to the MAKOplasty procedure that gave rise to this medical malpractice case. Although it’s possible, it is unlikely in our view that MAKO Surgical was not made aware of the malpractice suit. However, MAKO Surgical was not a named defendant in this case. Nonetheless, user facilities, like device manufacturers, are required to report adverse events. Among the reporting requirements are reporting “serious injuries” to the manufacturers (or FDA if the manufacturer is unknown) within 10 working days.